[Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2008] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR800.20] [Page 7-10] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 800_GENERAL--Table of Contents Subpart B_Requirements for Specific Medical Devices Sec. 800.20 Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration. (a) Purpose. The prevalence of human immunodeficiency virus (HIV), which causes acquired immune deficiency syndrome (AIDS), and its risk of transmission in the health care context, have caused the Food and Drug Administration (FDA) to look more closely at the quality control of barrier devices, such as surgeons' gloves and patient examination gloves (collectively known as medical gloves) to reduce the risk of transmission of HIV and other blood-borne infectious diseases. The Centers for Disease Control (CDC) recommend that health care workers wear medical gloves to reduce the risk of transmission of HIV and other blood-borne infectious deseases. The CDC recommends that health care workers wear medical gloves when touching blood or other body fluids, mucous membranes, or nonintact skin of all patients; when handling items or surfaces soiled with blood or other body fluids; and when performing venipuncture and other vascular access procedures. Among other things, CDC's recommendation that health care providers wear medical gloves demonstrates the proposition that devices labeled as medical gloves purport to be and are represented to be effective barriers against the transmission of blood- and fluid-borne pathogens. Therefore, FDA, through this regulation, is defining adulteration for patient examination and surgeons' gloves as a means of assuring safe and effective devices. (1) For a description of a patient examination glove, see Sec. 880.6250. Finger cots, however, are excluded from the [[Page 8]] test method and sample plans in paragraphs (b) and (c) of this section. (2) For a description of a surgeons' glove, see Sec. 878.4460 of this chapter. (b) Test method. For the purposes of this regulation, FDA's analysis of gloves for leaks will be conducted by a water leak method, using 1,000 milliliters (mL) of water. Each medical glove will be analyzed independently. When packaged as pairs, each glove is considered separately, and both gloves will be analyzed. A defect on one of the gloves is counted as one defect; a defect in both gloves is counted as two defects. Defects are defined as leaks, tears, mold, embedded foreigh objects, etc. A leak is defined as the appearance of water on the outside of the glove. This emergence of water from the glove constitutes a watertight barrier failure. Leaks within 1 and \1/2\ inches of the cuff are to be disregarded. (1) The following materials are required for testing: A 2\3/8\-inch by 15-inch (clear) plastic cylinder with a hook on one end and a mark scored 1\1/2\ inches from the other end (a cylinder of another size may be used if it accommodates both cuff diameter and any water above the glove capacity); elastic strapping with velcro or other fastening material; automatic water-dispensing apparatus or manual device capable of delivering 1,000 mL of water; a stand with horizontal rod for hanging the hook end of the plastic tube. The support rod must be capable of holding the weight of the total number of gloves that will be suspended at any one time, e.g., five gloves suspended will weigh about 11 pounds. (2) The following methodology is used: Examine the sample and identify code/ lot number, size, and brand as appropriate. Examine gloves for defects as follows: carefully remove the glove from the wrapper, box, etc., visually examining each glove for defects. Visual defects in the top 1\1/2\ inches of a glove will not be counted as a defect for the purposes of this rule. Visually defective gloves do not require further testing but are to be included in the total number of defective gloves counted for the sample. Attach the glove to the plastic fill tube by bringing the cuff end to the 1\1/2\-inch mark and fastening with elastic strapping to make a watertight seal. Add 1,000 mL of room temperature water (i.e., 20 [deg]C to 30 [deg]C) into the open end of the fill tube. The water shall pass freely into the glove. (With some larger sizes of long-cuffed surgeons' gloves, the water level may reach only the base of the thumb. With some smaller gloves, the water level may extend several inches up the fill tube.) (3) Immediately after adding the water, examine the glove for water leaks. Do not squeeze the glove; use only minimal manipulation to spread the fingers to check for leaks. Water drops may be blotted to confirm leaking. If the glove does not leak immediately, keep the glove/filling tube assembly upright and hang the assembly vertically from the horizontal rod, using the wire hook on the open end of the fill tube (do not support the filled glove while transferring). Make a second observation for leaks 2 minutes after addition of the water to the glove. Use only minimal manipulation of the fingers to check for leaks. Record the number of defective gloves. (c) Sample plans. FDA will collect samples from lots of gloves to perform the test for defects described in paragraph (b) of this section in accordance with FDA's sampling inspection plans which are based on the tables of MIL-STD-105E (the military sampling standard, ``Sampling Procedures and Tables for Inspection by Attributes,'' May 10, 1989). Based on the acceptable quality levels found in this standard, FDA has defined adulteration as follows: 2.5 or higher for surgeons' gloves and 4.0 or higher for patient examination gloves at a general inspection level II. FDA will use single normal sampling for lots of 1,200 gloves or less and multiple normal sampling for all larger lots. For convenience, the sample plans (sample size and accept/reject numbers) are shown in the following tables: [[Page 9]] Adulteration Level at 2.5 for Surgeons' Gloves ---------------------------------------------------------------------------------------------------------------- Number defective Lot size Sample Sample Number --------------------- size examined Accept Reject ---------------------------------------------------------------------------------------------------------------- 35,001 and above........................ First..................... 125 125 2 9 Second.................... 125 250 7 14 Third..................... 125 375 13 19 Fourth.................... 125 500 19 25 Fifth..................... 125 625 25 29 Sixth..................... 125 750 31 33 Seventh................... 125 875 37 38 35,000 to 10,001........................ First..................... 80 80 1 7 Second.................... 80 160 4 10 Third..................... 80 240 8 13 Fourth.................... 80 320 12 17 Fifth..................... 80 400 17 20 Sixth..................... 80 480 21 23 Seventh................... 80 560 25 26 10,000 to 3,201......................... First..................... 50 50 0 5 Second.................... 50 100 3 8 Third..................... 50 150 6 10 Fourth.................... 50 200 8 13 Fifth..................... 50 250 11 15 Sixth..................... 50 300 14 17 Seventh................... 50 350 18 19 3,200 to 1,201.......................... First..................... 32 32 0 4 Second.................... 32 64 1 6 Third..................... 32 96 3 8 Fourth.................... 32 128 5 10 Fifth..................... 32 160 7 11 Sixth..................... 32 192 10 12 Seventh................... 32 224 13 14 1,200 to 501............................ Single sample............. ......... 80 5 6 500 to 281.............................. Single sample............. ......... 50 3 4 280 to 151.............................. Single sample............. ......... 32 2 3 150 to 51............................... Single sample............. ......... 20 1 2 50 to 0................................. Single sample............. ......... 5 0 1 ---------------------------------------------------------------------------------------------------------------- Adulteration Level at 4.0 for Patient Examination Gloves ---------------------------------------------------------------------------------------------------------------- Number defective Lot size Sample Sample Number --------------------- size examined Accept Reject ---------------------------------------------------------------------------------------------------------------- 10,001 and above........................ First..................... 80 80 2 9 Second.................... 80 160 7 14 Third..................... 80 240 13 19 Fourth.................... 80 320 19 25 Fifth..................... 80 400 25 29 Sixth..................... 80 480 31 33 Seventh................... 80 560 37 38 10,000 to 3,201......................... First..................... 50 50 1 7 Second.................... 50 100 4 10 Third..................... 50 150 8 13 Fourth.................... 50 200 12 17 Fifth..................... 50 250 17 20 Sixth..................... 50 300 21 23 Seventh................... 50 350 25 26 3,200 to 1,201.......................... First..................... 32 32 0 5 Second.................... 32 64 3 8 Third..................... 32 96 6 10 Fourth.................... 32 128 8 13 Fifth..................... 32 160 11 15 Sixth..................... 32 192 14 17 Seventh................... 32 224 18 19 1,200 to 501............................ Single sample............. ......... 80 7 8 500 to 281.............................. Single sample............. ......... 50 5 6 280 to 151.............................. Single sample............. ......... 32 3 4 150 to 91............................... Single sample............. ......... 20 2 3 90 to 26................................ Single sample............. ......... 13 1 2 25 to 0................................. Single sample............. ......... 3 0 1 ---------------------------------------------------------------------------------------------------------------- [[Page 10]] (d) Lots of gloves which are tested and rejected using the test method according to paragraph (b) of this section, are adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act, and are subject to regulatory action, such as detention of imported products and seizure of domestic products. [55 FR 51256, Dec. 12, 1990] Effective Date Note: At 71 FR 75876, Dec. 19, 2006, Sec. 800.20 was amended by revising paragraphs (b), (c) and (d), effective Dec. 19, 2008. For the convenience of the user, the added and revised text is set forth as follows: [Page 10-14] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 800_GENERAL--Table of Contents Subpart B_Requirements for Specific Medical Devices Sec. 800.20 Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration. * * * * * (b)(1) General test method. For the purposes of this part, FDA's analysis of gloves for leaks and visual defects will be conducted by a visual examination and by a water leak test method, using 1,000 milliliters (ml) of water. (i) Units examined. Each medical glove will be analyzed independently. When packaged as pairs, each glove is considered separately, and both gloves will be analyzed. (ii) Identification of defects. For this test, defects include leaks detected when tested in accordance with paragraph (b)(3) of this section. A leak is defined as the appearance of water on the outside of the glove. This emergence of water from the glove constitutes a watertight barrier failure. Other defects include tears, embedded foreign objects, extrusions of glove material on the exterior or interior surface of the glove, gloves that are fused together so that individual glove separation is impossible, gloves that adhere to each other and tear when separated, or other visual defects that are likely to affect the barrier integrity. (iii) Factors for counting defects. One defect in one glove is counted as one defect. A defect in both gloves in a pair of gloves is counted as two defects. If multiple defects, as defined in paragraph (b)(1)(ii) of this section, are found in one glove, they are counted as one defect. Visual defects and leaks that are observed in the top 40 millimeters (mm) of a glove will not be counted as a defect for the purposes of this part. (2) Leak test materials. FDA considers the following to be the minimum materials required for this test : (i) A 60 mm by 380 mm (clear) plastic cylinder with a hook on one end and a mark scored 40 mm from the other end (a cylinder of another size may be used if it accommodates both cuff diameter and any water above the glove capacity); (ii) Elastic strapping with velcro or other fastening material; (iii) Automatic water-dispensing apparatus or manual device capable of delivering 1,000 ml of water; (iv) Stand with horizontal rod for hanging the hook end of the plastic tube. The horizontal support rod must be capable of holding the weight of the total number of gloves that will be suspended at any one time, e.g., five gloves suspended will weigh about 5 kilograms (kg); (v) Timer capable of measuring two minute intervals. (3) Visual defects and leak test procedures. Examine the sample and identify code/lot number, size, and brand as appropriate. Continue the visual examination using the following procedures: (i) Visual defects examination. Inspect the gloves for visual defects by carefully removing the glove from the wrapper, box, or package. Visually examine each glove for defects. As noted in paragraph (b)(1)(iii) of this section, a visual defect observed in the top 40 mm of a glove will not be counted as a defect for the purpose of this part. Visually defective gloves do not require further testing, although they must be included in the total number of defective gloves counted for the sample. (ii) Leak test set-up. (A) During this procedure, ensure that the exterior of the glove remains dry. Attach the glove to the plastic fill tube by bringing the cuff end to the 40 mm mark and fastening with elastic strapping to make a watertight seal. (B) Add 1,000 ml of room temperature water (i.e., 20 (deg)C to 30 (deg)C) into the open end of the fill tube. The water should pass freely into the glove. (With some larger sizes of long-cuffed surgeons' gloves, the water level may reach only the base of the thumb. With some smaller gloves, the water level may extend several inches up the fill tube.) (iii) Leak test examination. Immediately after adding the water, examine the glove for water leaks. Do not squeeze the glove; use only minimum manipulation to spread the fingers to check for leaks. Water drops may be blotted to confirm leaking. (A) If the glove does not leak immediately, keep the glove/filling tube assembly upright and hang the assembly vertically from the horizontal rod, using the wire hook on the open end of the fill tube (do not support the filled glove while transferring). (B) Make a second observation for leaks 2 minutes after the water is added to the glove. Use only minimum manipulation of the fingers to check for leaks. (C) Record the number of defective gloves. (c) Sampling, inspection, acceptance, and adulteration. In performing the test for leaks [[Page 11]] and other visual defects described in paragraph (b) of this section, FDA will collect and inspect samples of medical gloves, and determine when the gloves are acceptable as set out in paragraphs (c)(1) through (c)(3) of this section. (1) Sample plans. FDA will collect samples from lots of medical gloves in accordance with agency sampling plans. These plans are based on sample sizes, levels of sample inspection, and acceptable quality levels (AQLs) found in the International Standard Organization's standard ISO 2859, ``Sampling Procedures For Inspection By Attributes.'' (2) Sample sizes, inspection levels, and minimum AQLs. FDA will use single normal sampling for lots of 1,200 gloves or less and multiple normal sampling for all larger lots. FDA will use general inspection level II in determining the sample size for any lot size. As shown in the tables following paragraph (c)(3) of this section, FDA considers a 1.5 AQL to be the minimum level of quality acceptable for surgeons' gloves and a 2.5 AQL to be the minimum level of quality acceptable for patient examination gloves. (3) Adulteration levels and accept/reject criteria. FDA considers a lot of medical gloves to be adulterated when the number of defective gloves found in the tested sample meets or exceeds the applicable rejection number at the 1.5 AQL for surgeons' gloves or the 2.5 AQL for patient examination gloves. These acceptance and rejection numbers are identified in the tables following paragraph (c)(3) of this section as follows: [[Page 12]] Accept/Reject Criteria at 1.5 AQL for Surgeons' Gloves -------------------------------------------------------------------------------------------------------------------------------------------------------- Number Defective Lot Size Sample Sample Size Number Examined ------------------------------------- Accept Reject -------------------------------------------------------------------------------------------------------------------------------------------------------- 8 to 90 Single sample ................. 8 0 1 -------------------------------------------------------------------------------------------------------------------------------------------------------- 91 to 280 Single sample ................. 32 1 2 -------------------------------------------------------------------------------------------------------------------------------------------------------- 281 to 500 Single sample ................. 50 2 3 -------------------------------------------------------------------------------------------------------------------------------------------------------- 501 to 1,200 Single sample ................. 80 3 4 -------------------------------------------------------------------------------------------------------------------------------------------------------- 1,201 to 3,200 First 32 32 -- 4 Second 32 64 1 5 Third 32 96 2 6 Fourth 32 128 3 7 Fifth 32 160 5 8 Sixth 32 192 7 9 Seventh 32 224 9 10 -------------------------------------------------------------------------------------------------------------------------------------------------------- 3,201 to 10,000 First 50 50 0 4 Second 50 100 1 6 Third 50 150 3 8 Fourth 50 200 5 10 Fifth 50 250 7 11 Sixth 50 300 10 12 Seventh 50 350 13 14 -------------------------------------------------------------------------------------------------------------------------------------------------------- 10,001 to 35,000 First 80 80 0 5 Second 80 160 3 8 Third 80 240 6 10 Fourth 80 320 8 13 Fifth 80 400 11 15 Sixth 80 480 14 17 Seventh 80 560 18 19 -------------------------------------------------------------------------------------------------------------------------------------------------------- 35,000 First 125 125 1 7 Second 125 250 4 10 Third 125 375 8 13 Fourth 125 500 12 17 Fifth 125 625 17 20 Sixth 125 750 21 23 Seventh 125 875 25 26 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 13]] Accept/Reject Criteria at 2.5 AQL for Patient Examination Gloves ---------------------------------------------------------------------------------------------------------------- Number Defective Lot Size Sample Sample Size Number Examined ------------------------------------- Accept Reject ---------------------------------------------------------------------------------------------------------------- 5 to 50 Single sample ................. 5 0 1 ---------------------------------------------------------------------------------------------------------------- 51 to 150 Single sample ................. 20 1 2 ---------------------------------------------------------------------------------------------------------------- 151 to 280 Single sample ................. 32 2 3 ---------------------------------------------------------------------------------------------------------------- 281 to 500 Single sample ................. 50 3 4 ---------------------------------------------------------------------------------------------------------------- 501 to 1,200 Single sample ................. 80 5 6 ---------------------------------------------------------------------------------------------------------------- 1,201 to 3,200 First 32 32 0 4 Second 32 64 1 6 Third 32 96 3 8 Fourth 32 128 5 10 Fifth 32 160 7 11 Sixth 32 192 10 12 Seventh 32 224 13 14 ---------------------------------------------------------------------------------------------------------------- 3,201 to 10,000 First 50 50 0 5 Second 50 100 3 8 Third 50 150 6 10 Fourth 50 200 8 13 Fifth 50 250 11 15 Sixth 50 300 14 17 Seventh 50 350 18 19 ---------------------------------------------------------------------------------------------------------------- 10,001 to 35,000 First 80 80 1 7 Second 80 160 4 10 Third 80 240 8 13 Fourth 80 320 12 17 Fifth 80 400 17 20 Sixth 80 480 21 23 Seventh 80 560 25 26 ---------------------------------------------------------------------------------------------------------------- 35,000 and above First 125 125 2 9 Second 125 250 7 14 Third 125 375 13 19 Fourth 125 500 19 25 Fifth 125 625 25 29 Sixth 125 750 31 33 Seventh 125 875 37 38 ---------------------------------------------------------------------------------------------------------------- (d) Compliance. Lots of gloves that are sampled, tested, and rejected using procedures in paragraphs (b) and (c) of this section, are considered adulterated within the meaning of section 501(c) of the act. (1) Detention and seizure. Lots of gloves that are adulterated under section 501(c) of the act are subject to administrative and judicial action, such as detention of imported products and seizure of domestic products. (2) Reconditioning. FDA may authorize the owner of the product, or the owner's representative, to attempt to recondition, i.e., bring into compliance with the act, a lot or part of a lot of foreign gloves detained at importation, or a lot or part of a lot of seized domestic gloves. (i) Modified sampling, inspection, and acceptance. If FDA authorizes reconditioning of a lot or portion of a lot of adulterated gloves, testing to confirm that the reconditioned gloves meet AQLs must be performed by an independent testing facility. The following tightened sampling plan must be followed, as described in ISO 2859 ``Sampling Procedures for Inspection by Attributes:'' (A) General inspection level II, (B) Single sampling plans for tightened inspection, (C) 1.5 AQL for surgeons' gloves, and (D) 2.5 AQL for patient examination gloves. (ii) Adulteration levels and acceptance criteria for reconditioned gloves. (A) FDA considers a lot or part of a lot of adulterated gloves, that is reconditioned in accordance with paragraph (d)(2)(i) of this section, to be acceptable when the number of defective gloves found in the tested sample does not exceed the acceptance number in the appropriate tables in paragraph (d)(2)(ii)(B) of this section for reconditioned surgeons' gloves or patient examination gloves. (B) FDA considers a reconditioned lot of medical gloves to be adulterated within the meaning of section 501(c) of the act when the [[Page 14]] number of defective gloves found in the tested sample meets or exceeds the applicable rejection number in the tables following paragraph (d)(2)(ii)(B) of this section: Accept/Reject Criteria at 1.5 AQL for Reconditioned Surgeons' Gloves ---------------------------------------------------------------------------------------------------------------- Number Defective Lot Size Sample Sample Size ------------------------------------- Accept Reject ---------------------------------------------------------------------------------------------------------------- 13 to 90 Single sample 13 0 1 ---------------------------------------------------------------------------------------------------------------- 91 to 500 Single sample 50 1 2 ---------------------------------------------------------------------------------------------------------------- 501 to 1,200 Single sample 80 2 3 ---------------------------------------------------------------------------------------------------------------- 1,201 to 3,200 Single sample 125 3 4 ---------------------------------------------------------------------------------------------------------------- 3,201 to 10,000 Single sample 200 5 6 ---------------------------------------------------------------------------------------------------------------- 10,001 to 35,000 Single sample 315 8 9 ---------------------------------------------------------------------------------------------------------------- 35,000 and above Single sample 500 12 13 ---------------------------------------------------------------------------------------------------------------- Accept/Reject Criteria at 2.5 AQL for Reconditioned Patient Examination Gloves ---------------------------------------------------------------------------------------------------------------- Number Defective Lot Size Sample Sample Size ------------------------------------- Accept Reject ---------------------------------------------------------------------------------------------------------------- 8 to 50 Single sample 8 0 1 ---------------------------------------------------------------------------------------------------------------- 51 to 280 Single sample 32 1 2 ---------------------------------------------------------------------------------------------------------------- 281 to 500 Single sample 50 2 3 ---------------------------------------------------------------------------------------------------------------- 501 to 1,200 Single sample 80 3 4 ---------------------------------------------------------------------------------------------------------------- 1,201 to 3,200 Single sample 125 5 6 ---------------------------------------------------------------------------------------------------------------- 3,201 to 10,000 Single sample 200 8 9 ---------------------------------------------------------------------------------------------------------------- 10,001 to 35,000 Single sample 315 12 13 ---------------------------------------------------------------------------------------------------------------- 35,000 and above Single sample 500 18 19 ----------------------------------------------------------------------------------------------------------------